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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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Silicone Eye Sphere - 22mm - B091143560

Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis.
Gulden Ophthalmics Inc.
14356
Not in Commercial Distribution

  • B091143560 ()

  • Outer Diameter: 22 Millimeter
14356

  • Orbital sphere implant

Silicone Eye Sphere - 20mm - B091143550

Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis.
Gulden Ophthalmics Inc.
14355
Not in Commercial Distribution

  • B091143550 ()

  • Outer Diameter: 20 Millimeter
14355

  • Orbital sphere implant

Silicone Eye Sphere - 18mm - B091143540

Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis.
Gulden Ophthalmics Inc.
14354
Not in Commercial Distribution

  • B091143540 ()

  • Outer Diameter: 18 Millimeter
14354

  • Orbital sphere implant

Silicone Eye Sphere - 16mm - B091143530

Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis.
Gulden Ophthalmics Inc.
14353
Not in Commercial Distribution

  • B091143530 ()

  • Outer Diameter: 16 Millimeter
14353

  • Orbital sphere implant

Silicone Eye Sphere - 14mm - B091143520

Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis.
Gulden Ophthalmics Inc.
14352
Not in Commercial Distribution

  • B091143520 ()

  • Outer Diameter: 14 Millimeter
14352

  • Orbital sphere implant

Silicone Eye Sphere - 12mm - B091143510

Silicone Eye Sphere is implanted within the eye sac during evisceration or enucleation surgery to enable the future use of a prosthesis.
Gulden Ophthalmics Inc.
14351
Not in Commercial Distribution

  • B091143510 ()

  • Outer Diameter: 12 Millimeter
14351

  • Orbital sphere implant

22mm Sterile Orbital Implant (PMMA) - B091142560

No Description
Gulden Ophthalmics Inc.
14256
In Commercial Distribution

  • B091142560 ()

  • Outer Diameter: 22 Millimeter
14256

  • Orbital sphere implant

20mm Sterile Orbital Implant (PMMA) - B091142550

No Description
Gulden Ophthalmics Inc.
14255
In Commercial Distribution

  • B091142550 ()

  • Outer Diameter: 20 Millimeter
14255

  • Orbital sphere implant

18mm Sterile Orbital Implant (PMMA) - B091142540

No Description
Gulden Ophthalmics Inc.
14254
In Commercial Distribution

  • B091142540 ()

  • Outer Diameter: 18 Millimeter
14254

  • Orbital sphere implant

16mm Sterile Orbital Implant (PMMA) - B091142530

No Description
Gulden Ophthalmics Inc.
14253
In Commercial Distribution

  • B091142530 ()

  • Outer Diameter: 16 Millimeter
14253

  • Orbital sphere implant
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